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Completed

NCT Number: NCT04467138

High Dose Intravenous Fish Oil Reduces Inflammation

Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed.

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Key information

Conditions

Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

About this study

All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. The aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as part of short- and long term PN in patients either at risk or with already existing inflammation.

Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF and 21days for UC and CD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age,
  • metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
  • ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.

Exclusion criteria

  • patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.

Treatment and study plan

Omegaven

Drug

Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d.

Other names: Fish oil

Primary outcomes

  1. Change in hsCRP concentration

    Time frame: 4 weeks

    Serum concentration of hsCRP (pg/mL)

  2. Change in Il-6 concentration

    Time frame: 4 weeks

    Serum concentration of Il-6 (pg/mL)

  3. Change in interleukin-10 concentration

    Time frame: 4 weeks

    Serum concentration of IL-10 (pg/mL)

  4. Change in procalcytonin concentration

    Time frame: 4 weeks

    Serum concentration of procalcytonin (ng/mL)

  5. Change in bilirubin concentration

    Time frame: 4 weeks

    Serum concentration of bilirubin (umol/L)

  6. Change in SGPT concentration

    Time frame: 4 weeks

    Serum concentration of SGPT(U/l)

  7. Change in SGOT concentration

    Time frame: 4 weeks

    Serum concentration of SGOT (U/l)

  8. Change in alkaline phosphatase concentration

    Time frame: 4 weeks

    Serum concentration of alkaline phosphatase (U/l)

  9. Change in C-reactive protein concentration

    Time frame: 4 weeks

    Serum concentration of CRP (mg/l)

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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